FDA-Drug2024-12-25Class II
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
Keystone Industries
Hazard
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Sold states
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Manufactured in
480 S Democrat Rd, Gibbstown, NJ, United States
Products
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0147-2025Don't want to check this manually?
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